Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 75885 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 71 

[Docket No. CDC–2012–0017] 

RIN 0920–AA12 

Control of Communicable Diseases: 

Foreign; Scope and Definitions 

AGENCY: Centers for Disease Control and 

Prevention (HHS/CDC), Department of 

Health and Human Services (HHS). 

ACTION: Direct Final Rule and request for 

comments. 

SUMMARY: Through this Direct Final 

Rule, the Centers for Disease Control 

and Prevention (CDC), located within 

the Department of Health and Human 

Services (HHS) is updating and 

reorganizing the Scope and Definitions 

for foreign quarantine regulations and 

add a new section to contain definitions 

for Importations. This Direct Final Rule 

(DFR) will update the scope and 

definitions to reflect modern 

terminology and plain language used 

globally by industry and public health 

partners. As part of the update, we are 

updating five existing definitions; 

adding thirteen new definitions to help 

clarify existing provisions; creating a 

new scope and definitions section for 

Importations under a new section by 

reorganizing existing definitions into 

this new section; and updating 

regulations to reflect the language used 

by the most recent Executive Order 

regarding quarantinable communicable 

diseases. 

DATES: The direct final rule is effective 

on February 25, 2013 unless significant 

adverse comment is received by January 

25, 2013. If we receive no significant 

adverse comments within the specified 

comment period, we intend to publish 

a document confirming the effective 

date of the final rule in the Federal 

Register within 30 days after the 

comment period on this DFR ends. If we 

receive any timely significant adverse 

comment, we will withdraw this final 

rule in part or in whole by publication 

of a document in the Federal Register 

within 30 days after the comment 

period ends. 

ADDRESSES: You may submit comments, 

identified by ‘‘RIN 0920–AA12’’: by any 

of the following methods: 

• Internet: Access the Federal eRulemaking Portal at http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Division of Global Migration 

and Quarantine, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road NE., MS–03, Atlanta, Georgia 

30333, ATTN: Part 71 DFR. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulation Identifier 

Number (RIN) for this rulemaking. All 

relevant comments will be posted 

without change to http:// 

regulations.gov, including any personal 

information provided. For detailed 

instructions on submitting comments 

and additional information on the 

rulemaking process, see the ‘‘Public 

Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, please go to 

http://www.regulations.gov. Comments 

will also be available for public 

inspection Monday through Friday, 

except for legal holidays, from 9 a.m. 

until 5 p.m., Eastern Standard Time, at 

1600 Clifton Road NE., Atlanta, Georgia 

30333. Please call ahead to 1–866–694– 

4867 and ask for a representative in the 

Division of Global Migration and 

Quarantine (DGMQ) to schedule your 

visit. To download an electronic version 

of the rule, access http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: For 

questions concerning this direct final 

rule: Ashley A. Marrone, JD, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE., Mailstop E–03, 

Atlanta, Georgia 30333; telephone 404– 

498–1600. 

SUPPLEMENTARY INFORMATION: HHS/CDC 

is publishing a direct final rule (DFR) 

because it does not expect to receive any 

significant adverse comments and 

believes that updating scope and 

definitions to add clarity to the 

regulations is non-controversial. 

However, in this Federal Register, HHS/ 

CDC is simultaneously publishing a 

companion notice of proposed 

rulemaking (NPRM) that proposes 

identical updates. If HHS/CDC does not 

receive any significant adverse 

comments on this DFR within the 

specified comment period, we will 

publish a document in the Federal 

Register confirming the effective date of 

this final rule within 30 days after the 

comment period on the DFR ends and 

withdraw the NPRM. If HHS/CDC 

receives any timely significant adverse 

comment, we will withdraw the DFR in 

part or in whole by publication of a 

document in the Federal Register 

within 30 days after the public comment 

period ends. If the DFR is withdrawn, 

we will carefully consider all public 

comments before proceeding with any 

subsequent final rule based on the 

NPRM. A significant adverse comment 

is one that explains: (1) Why the DFR is 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach; or (2) why the DFR will be 

ineffective or unacceptable without a 

change. 

This preamble is organized as follows: 

I. Public Participation 

II. Authority for These Regulations 

III. Rationale for Direct Final Rule 

IV. Updates to 42 CFR 71.1, 71.32(a) and 

71.50 

V. Scope and Definitions for Section 71.1 

A. Definitions Updated under Section 71.1 

B. Definitions Added to Section 71.1 

VI. Update of Section 71.32(a) 

VII. Scope and Definitions for Section 71.5 

A. Definitions Added to Section 71.50 

VIII. Alternatives Considered 

IX. Required Regulatory Analysis 

A. Required Regulatory Analyses under 

Executive Orders 12866 and 13563 

B. Regulatory Flexibility Act 

C. Small Business Regulatory Enforcement 

Fairness Act of 1996 

D. The Paperwork Reduction Act of 1995 

E. National Environmental Policy Act 

(NEPA) 

F. Civil Justice Reform (Executive Order 

12988) 

G. Executive Order 13132 (Federalism) 

H. Plain Language Act of 2010 

I. Public Participation. 

Interested persons are invited to 

participate in this rulemaking by 

submitting written views, opinions, 

recommendations, and data. Comments 

received, including attachments and 

other supporting materials, are part of 

the public record and subject to public 

disclosure. Do not include any 

information in your comment or 

supporting materials that you do not 

wish to be disclosed publicly. 

Comments are invited on any topic 

related to this DFR. 

II. Authority for These Regulations. 

The primary authority supporting this 

rulemaking is section 361 of the Public 

Health Service Act (42 U.S.C. 264). 

Section 361 authorizes the Secretary of 

HHS to make and enforce regulations as 

in the Secretary’s judgment are 

necessary to prevent the introduction, 

transmission, or spread of 

communicable diseases from foreign 

countries into the states or possessions 

of the United States and from one state 

or possession into any other state or 

possession. Regulations that implement 

federal quarantine authority are 

currently promulgated in 42 CFR Parts 

70 and 71. Part 71 contains regulations 

to prevent the introduction, 

transmission, and spread of 

communicable diseases into the states 

and possessions of the United States, 

while Part 70 contains regulations to 


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75886 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 

prevent the introduction, transmission, 

or spread of communicable diseases 

from one state into another. CDC is 

updating the term ‘‘possession’’ to 

‘‘territory.’’ The U.S. Department of the 

Interior’s Office of Insular Affairs, the 

lead federal agency on issues involving 

the territories, no longer uses the term 

‘‘possession’’ to refer to the insular 

areas. Therefore, CDC is adopting the 

predominant term ‘‘territory’’ consistent 

with how other federal agencies use this 

term. The Secretary has delegated to the 

Director of the Centers for Disease 

Control and Prevention the authority for 

implementing these regulations. 

Authority for carrying out most of 

these functions has been delegated to 

HHS/CDC’s Division of Global 

Migration and Quarantine (DGMQ). The 

Secretary’s authority to apprehend, 

examine, detain, and conditionally 

release individuals is limited to those 

quarantinable communicable diseases 

published in an Executive Order of the 

President. This list currently includes 

cholera, diphtheria, infectious 

tuberculosis (TB), plague, smallpox, 

yellow fever, and viral hemorrhagic 

fevers, such as Marburg, Ebola, and 

Crimean-Congo hemorrhagic fever 

(CCHF), Severe Acute Respiratory 

Syndrome (SARS), and influenza caused 

by novel or re-emergent influenza 

viruses that are causing or have the 

potential to cause a pandemic (see 

Executive Order 13295, as amended by 

Executive Order 13375 on April 1, 

2005). 

III. Rationale for Direct Final Rule 

Through this Direct Final Rule (DFR), 

HHS/CDC is updating the scope and 

definitions to part 71 to reflect modern 

science and current practices. HHS/CDC 

has chosen to publish a DFR because we 

view this as a non-controversial action 

and anticipate no significant adverse 

comment. This DFR does not create any 

additional requirements or burden upon 

the regulated community nor does it 

alter current HHS/CDC practices. 

A significant adverse comment is one 

that explains: (1) Why the DFR is 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach; or (2) why the DFR will be 

ineffective or unacceptable without a 

change. In determining whether a 

comment necessitates withdrawal of 

this DFR, HHS/CDC will consider 

whether it warrants a substantive 

response through a notice and comment 

process. If we receive significant 

adverse comment on this DFR, we will 

publish a timely withdrawal in the 

Federal Register informing the public 

that the amendments in this rule will 

not take effect. If this DFR is withdrawn, 

we will carefully consider all public 

comments before proceeding with any 

subsequent final rule based on the 

NPRM which is being published 

simultaneously in the Federal Register. 

IV. Updates to 42 CFR 71.1, 71.32(a) 

and 71.50 

Through this DFR, HHS/CDC is 

updating the Scope and Definitions for 

42 CFR Part 71 under section 71.1 and 

adding a new section 71.50, to reflect 

modern terminology and plain language 

commonly used by global private sector 

industry and public health partners. 

Specifically, we are updating five 

existing definitions, adding thirteen 

new definitions to help clarify existing 

provisions, and creating a new scope 

and definitions section within Part 71, 

under subpart F for Importations, by 

reorganizing certain existing definitions. 

In updating the definitions in Part 71, it 

became evident to us that certain 

definitions pertain more directly to 

Importations under subpart F than to 

Part 71 in general; therefore, we decided 

to reorganize the existing definitions by 

creating a new section 71.50 for this 

subpart to better clarify these terms for 

importers. We are also adding new 

definitions that have been crafted for 

section 71.50 to help clarify the intent 

of certain provisions under subpart F. 

Finally, as part of the changes to 

definitions, we are also updating section 

71.32(a) to incorporate the most recent 

listing of quarantinable communicable 

diseases under Executive Order 13295, 

of April 4, 2003, as amended by 

Executive Order 13375 of April 1, 2005. 

These changes are not substantive and 

will not affect current practices. 

V. Scope and Definitions for Part 71.1 

Section 71.1(a) has been updated to 

include the current interstate quarantine 

regulations administered by HHS/CDC 

found at ‘‘42 CFR part 70’’ to the 

existing cross-reference citing ‘‘21 CFR 

parts 1240 and 1250.’’ 

On August 16, 2000, the Secretary 

transferred certain authority for 

interstate control of communicable 

disease, including the authority to 

apprehend, examine, detain, and 

conditionally release individuals 

moving from one state into another from 

HHS/Food and Drug Administration 

(FDA) to CDC, which became 42 CFR 

Part 70. As part of this transfer, FDA 

retained regulatory authority over 

animals and other products that may 

transmit or spread communicable 

disease. These other regulations may be 

found at 21 CFR parts 1240 and 1250. 

This rule has no effect upon FDA’s 

regulatory authority. Accordingly, the 

new scope will read: ‘‘The provisions of 

this part contain the regulations to 

prevent the introduction, transmission, 

and spread of communicable disease 

from foreign countries into the States or 

territories (also known as possessions) 

of the United States. Regulations 

pertaining to preventing the interstate 

spread of communicable diseases are 

contained in 21 CFR parts 1240 and 

1250 and 42 CFR part 70.’’ 

Current section 71.1 (b) Definitions 

contains definitions used in the current 

CFR. This DFR adds new definitions 

and updates certain definitions for 

clarification and to be consistent with 

current industry and public health 

principles and practice. 

Table 1 list the definitions found in 

the current 42 CFR part 71, subpart A, 

and compares them with the updated 

definitions in this DFR. 

TABLE 1—SUBPART A—FOREIGN QUARANTINE

DEFINITIONS AND CORRESPONDING CHANGES IN DEFINITIONS IN THE DFR 

Existing definitions in 42 CFR 71.1 Corresponding, new or updated definition in DFR 

Carrier ....................................................................................................... No Change. 

Commander. 

Communicable disease ............................................................................ No Change. 

Contamination ........................................................................................... No Change. 

Controlled Free Pratique .......................................................................... No Change. 

Deratting Certificate .................................................................................. No Change. 

Deratting Exemption Certificate ................................................................ No Change. 

Detention .................................................................................................. No Change. 

Director ..................................................................................................... No Change. 

Disinfection ............................................................................................... No Change. 


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TABLE 1—SUBPART A—FOREIGN QUARANTINE—Continued 

DEFINITIONS AND CORRESPONDING CHANGES IN DEFINITIONS IN THE DFR 

Existing definitions in 42 CFR 71.1 Corresponding, new or updated definition in DFR 

Disinfestation ............................................................................................ No Change. 

Disinsection .............................................................................................. No Change. 

Educational Purpose ................................................................................ Moved to new 71.50. 

Exhibition Purpose .................................................................................... Moved to new 71.50. 

Ill person ................................................................................................... No Change. 

International Health Regulations .............................................................. Updated. 

International voyage ................................................................................. No Change. 

Isolation .................................................................................................... Updated. 

Military Services ....................................................................................... No Change. 

Quarantine. 

Quarantinable Communicable disease. 

Possession. 

Scientific Purpose ..................................................................................... Moved to new 71.50. 

Surveillance .............................................................................................. Updated. 

U.S. port ................................................................................................... No Change. 

U.S. Territory. 

United States ............................................................................................ Updated. 

Vector ....................................................................................................... Updated. 

A. Definitions Updated Under Section 

71.1 

International Health Regulations or 

IHR. This DFR defines International 

Health Regulations or IHR as the 

International Health Regulations of the 

World Health Organization (WHO), 

adopted by the 58th World Health 

Assembly in 2005, as may be further 

amended, and subject to the United 

States’ reservation and understandings. 

The DFR updates the current CFR’s 

definition to reflect that the 1969 IHR, 

as amended in 1973 and 1981 by the 

World Health Assembly, has been 

superseded by the 2005 IHR currently in 

place. This definition also reflects that 

the United States accepted the IHR with 

the reservation that it will implement 

them in line with U.S. principles of 

federalism. In addition, the United 

States submitted three understandings, 

setting forth its views that: (1) Incidents 

that involve the natural, accidental or 

deliberate release of chemical, biological 

or radiological materials are notifiable 

under the IHR; (2) countries that accept 

the IHR are obligated to report potential 

public health emergencies that occur 

outside their borders to the extent 

possible; and (3) the IHR do not create 

any separate private right to legal action 

against the federal government. 

Isolation. The DFR defines the term 

‘‘isolation’’ as the separation of an 

individual or group of individuals who 

are reasonably believed to be infected 

with a quarantinable communicable 

disease from others who are healthy in 

such a manner as to prevent the spread 

of the quarantinable communicable 

disease. The current definition of 

‘‘isolation,’’ when applied to an 

individual or group of individuals, is 

stated as ‘‘the separation of that person 

or group of persons from other persons, 

except the health staff on duty, in such 

a manner as to prevent the spread of 

infection.’’ Not only does the updated 

definition help to clarify the distinction 

between quarantine and isolation, but it 

removes the current reference to ‘‘health 

staff on duty’’ to which the separation 

does not apply. HHS/CDC believes that 

the reference to ‘‘health staff on duty’’ 

is unnecessary and outmoded because, 

in practice, a patient may have his or 

her needs attended to by a variety of 

individuals. The new definition focuses 

on the measures used to prevent the 

spread of infection and not on the types 

of individuals who may attend to the 

patient. This is not a substantive change 

from current practice. 

Surveillance. Under this DFR, 

‘‘surveillance’’ is defined as the 

temporary supervision by a public 

health official (or designee) of an 

individual or group, who may have been 

exposed to a quarantinable 

communicable disease, to determine the 

risk of disease spread. We have updated 

the term ‘‘surveillance’’ to more 

accurately reflect current practice and to 

clarify that, just as with quarantine and 

isolation, this public health measure is 

applicable to individuals and groups of 

individuals. 

United States. We have updated the 

definition of ‘‘United States’’ to mean 

the 50 States, the District of Columbia, 

and the territories (also known as 

possessions) of the United States, 

including American Samoa, Guam, the 

Northern Mariana Islands, the 

Commonwealth of Puerto Rico, and the 

U.S. Virgin Islands. We have taken this 

action to better clarify the authority of 

provisions within Part 71. The current 

definition includes the Trust Territory 

of the Pacific Islands, which have not 

been administered by the United States 

since 1986. 

Vector. We have updated the term 

‘‘vector’’ to be defined as any animals 

(vertebrate or invertebrate) including 

arthropods or any noninfectious selfreplicating system (e.g., plasmids or 

other molecular vector) or animal 

products that are known to transfer, or 

are capable of transferring, an infectious 

biological agent to a human. To provide 

further clarity, we have defined the term 

‘‘animal products’’ in subpart F. This 

revision more adequately reflects 

modern science and current practice 

which are focused on protecting public 

health. 

B. Definitions Added to Section 71.1 

Commander. Consistent with current 

industry practice, this DFR defines 

‘‘commander’’ as the aircrew member 

with responsibility for the aircraft’s 

operations and navigation. 

Quarantine. ‘‘Quarantine’’ is defined 

as the separation of an individual or 

group of individuals who are reasonably 

believed to have been exposed to a 

quarantinable communicable disease, 

but who are not yet ill, from others who 

have not been so exposed, in such a 

manner as to prevent the possible 

spread of the quarantinable 

communicable disease. HHS/CDC is 

separately defining quarantine, 

isolation, and surveillance, and is using 

these terms in a manner that is 

consistent with public health practice. 

In current practice, quarantine, 

isolation, and surveillance may apply 

either to individuals or groups of 

individuals. Indeed, the current 

definition of Isolation in 42 CFR 71.1 


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applies to ‘‘a person or group of 

persons.’’ HHS/CDC is clarifying that 

quarantine and surveillance are public 

health practices that may also be 

applied to groups of individuals. This is 

not a substantive change, but rather 

consistent with CDC’s current practice. 

Quarantinable communicable 

disease. ‘‘Quarantinable communicable 

disease’’ is defined as any of the 

communicable diseases listed in an 

Executive Order, as provided under 

section 361 of the Public Health Service 

Act (42 U.S.C. 264). Executive Order 

13295, of April 4, 2003, as amended by 

Executive Order 13375 of April 1, 2005, 

contains the current revised list of 

quarantinable communicable diseases, 

and may be obtained at http:// 

www.cdc.gov and http:// 

www.archives.gov/federal_register. If 

this Order is amended, HHS will 

enforce that amended order 

immediately and update the appropriate 

Web site. A new definition for 

‘‘quarantinable communicable disease’’ 

is being added to part 71 through this 

DFR to incorporate the most recent 

Executive Order. The addition of this 

new definition will also be reflected in 

section 71.32(a), Persons, carriers and 

things. 

Possession. To best add clarity to part 

71 and to align this part with 42 CFR 

part 70, we have updated the term 

‘‘possession’’ to mean ‘‘U.S. territory’’ 

and defined U.S. territory to include 

American Samoa, Guam, the 

Commonwealth of the Northern Mariana 

Islands, the Commonwealth of Puerto 

Rico, and the U.S. Virgin Islands. 

Currently, only Puerto Rico and the 

Virgin Islands are explicitly listed in the 

definition. Thus, CDC is updating this 

provision to explicitly list the other U.S. 

jurisdictions to which this part applies. 

U.S. territory. Under this DFR, ‘‘U.S. 

territory’’ means any territory (also 

known as possessions) of the United 

States including American Samoa, 

Guam, the Commonwealth of the 

Northern Mariana Islands, the 

Commonwealth of Puerto Rico, and the 

U.S. Virgin Islands. The Department of 

the Interior’s Office of Insular Affairs, 

the federal government’s lead agency for 

U.S. territories, no longer uses the term 

‘‘possession’’ to refer to these 

jurisdictions. Consequently, HHS/CDC 

is adding a new definition for U.S. 

territory consistent with current federal 

usage. 

VI. Update of Section 71.32(a) 

In 2003, in response to the emergence 

of Severe Acute Respiratory Syndrome 

(SARS), HHS amended 42 CFR 70.6 and 

71.32 to incorporate by reference the 

Executive Order listing the 

quarantinable communicable diseases 

subject to detention, isolation, 

quarantine, or conditional release, 

thereby eliminating the administrative 

delay involved in separately publishing 

the list of diseases through rulemaking. 

Section 71.32(a), Persons, carriers, 

and things, contains the general 

authority for the Director to take 

measures to protect public health 

against ‘‘any of the communicable 

diseases listed in an Executive Order, as 

provided under section 361(b) of the 

Public Health Service Act.’’ The current 

§ 71.32(a) lists Executive Order (E.O.) 

13295, of April 4, 2003. The subpart 

states that ‘‘If this Order is amended, 

HHS will enforce that amended order.’’ 

On April 1, 2005, the existing 

Executive Order was amended by 

Executive Order 13375. Therefore, as 

part of the non-controversial changes in 

this DFR, we are also updating section 

71.32(a) to reflect the most recent 

Executive Order that lists the 

‘‘Quarantinable Communicable 

Diseases,’’ which we have also defined. 

These changes are not substantive and 

will not affect current practices. 

VII. Scope and Definitions for Section 

71.50 

This DFR moves certain definitions 

from section 71.1 to new section 71.50, 

because these definitions only apply to 

the regulations found in subpart F, 

Importations. Subpart F, Importations, 

contains the restrictions on importations 

of nonhuman primates; certain kinds of 

animals; etiological agents, hosts, and 

vectors; and dead bodies. The addition 

of § 71.50 Scope and Definitions is not 

a substantive change. To clarify the 

regulations for the reader, the terms 

used only in subpart A through subpart 

G are found in § 71.1, while the terms 

used only in subpart F, have been 

moved to new § 71.50. We have also 

separated definitions for quarantine and 

isolation to reflect current practices as 

they apply to individuals (§ 71.1) and 

animals (§ 71.50). 

Section 71.50(a) Scope under subpart 

F—Importations, clarifies that HHS/ 

CDC also has the statutory authority to 

prevent the introduction, transmission, 

and spread of communicable human 

diseases resulting from importations of 

various animal hosts, product, vectors, 

or other etiological agents that pose a 

threat to human health. 

Section 71.50(b) Definitions contains 

updated definitions used in the current 

CFR. The DFR promulgates new and 

updated definitions to be consistent 

with current medical and public health 

principles and practice. 

Table 2 lists the definitions found in 

the 42 CFR part 71, subpart A, prior to 

the DFR and the definitions retained in 

this final rule. 

TABLE 2—SUBPART F—Importations 

DEFINITIONS AND CORRESPONDING CHANGES IN DEFINITIONS IN THE DFR 

Existing definitions in 42 CFR 71.1 Corresponding, new and modified definition in DFR § 71.50 

Animal product or Product. 

Educational purpose ................................................................................. No Change. 

Exhibition purpose .................................................................................... No Change. 

In transit. 

Isolation, when applied to animals. 

Licensed Veterinarian. 

Person. 

Quarantine, when applied to animals. 

Rendered Noninfectious. 

Scientific purpose ..................................................................................... No Change. 

You or Your. 

A. Definitions Added to Section 71.50 

Animal Product or Product. We have 

defined the term ‘‘animal product’’ or 

‘‘product’’ to describe those items that 

are known to transfer, or are capable of 

transferring, an infectious biological 

agent to a human and that are 

prohibited from entering the United 

States unless accompanied by a permit 


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or rendered noninfectious. For the 

purposes of this DFR, ‘‘animal product’’ 

or ‘‘product’’ means the hide, hair, 

skull, teeth, bones, claws, blood, tissue, 

or other biological samples from an 

animal, including trophies, mounts, 

rugs, or other display items. We have 

added this definition, which is used in 

subpart F, to best describe the current 

prohibition on animal products that are 

known to transfer, or are capable of 

transferring, an infectious biological 

agent to a human and that as a condition 

of entry into the United States must be 

accompanied by a permit or rendered 

noninfectious. 

In transit. In this DFR, we have 

defined ‘‘in transit’’ as animals that are 

located within the United States, 

including animals whose presence is 

anticipated, scheduled, or otherwise, as 

part of the movement of those animals 

between a foreign country of departure 

and foreign country of final destination 

without clearing customs and officially 

entering the United States. As part of 

modern global trade and travel 

practices, animals commonly pass 

through the United States without being 

formally admitted into this country. 

These animals pose a potential risk to 

U.S. public health where the improper 

handling of these shipments during 

exchange of cargo could introduce 

zoonotic diseases into the United States. 

We note that the term ‘‘in-transit’’ is 

currently only found in section 71.51 

relating to the importation of dogs and 

cats and we believe it is useful to add 

clarity to this section by defining what 

is meant by this term. 

Isolation, when applied to animals. 

To distinguish the concept of isolation 

for individuals from isolation of 

animals, we have defined ‘‘isolation’’ 

under this subpart to mean the 

separation of an ill animal or ill group 

of animals from individuals, other 

animals, or vectors of disease in such a 

manner as to prevent the spread of 

infection. 

Licensed Veterinarian. We have 

defined ‘‘licensed veterinarian’’ to mean 

an individual who has obtained both an 

advanced degree and a valid license to 

practice animal medicine. This new 

definition best describes the intent of 

provisions of this subpart. 

Person. We have defined ‘‘person’’ to 

mean any individual or partnership, 

firm, company, corporation, association, 

organization, or similar legal entity, 

including those that are not-for-profit. 

With the exception of 42 C.F.R. section 

71.55, which refers to the imported 

remains of a natural person, this 

definition is intended to clarify the 

relevant import prohibitions applicable 

to individuals and organizations under 

this subpart. 

Quarantine, when applied to animals. 

We have defined ‘‘quarantine’’ as it 

applies to animals as the practice of 

separating live animals that are 

reasonably believed to have been 

exposed to a communicable disease, but 

are not yet ill, in a setting where the 

animal can be observed for evidence of 

disease, and where measures are in 

place to prevent transmission of 

infection to humans or animals. This 

new definition best clarifies the current 

public health measure of quarantining 

animals, and it distinguishes it from 

public health practice of isolation when 

applied to animals. 

Render Noninfectious. For purposes 

of this DFR, to ‘‘render noninfectious’’ 

means ‘‘treating an animal product (e.g., 

by boiling, irradiating, soaking, formalin 

fixation, or salting) in such a manner 

that renders the product incapable of 

transferring an infectious biological 

agent to a human.’’ 

Acceptable methods of rendering a 

product noninfectious typically include 

the following: 

(1) Boiling in water to ensure that any 

matter other than bone, horns, hooves, 

claws, antlers, or teeth is removed, 

(2) Irradiating with gamma irradiation 

at a dose of at least 20 kilogray at room 

temperature (20° C or higher), 

(3) Soaking, with agitation, in a 4 

percent (weight/volume) solution of 

washing soda (sodium carbonate, 

Na2CO3) maintained at pH 11.5 or above 

for at least 48 hours, 

(4) Soaking, with agitation, in a formic 

acid solution (100 kg salt [sodium 

chloride, NaCl] and 12 kg formic acid 

per 1,000 liters water) maintained at 

below pH 3.0 for at least 48 hours; 

wetting and dressing agents may be 

added. 

(5) In the case of raw hides, salting for 

at least 28 days with sea salt containing 

2 percent washing soda (sodium 

carbonate, Na2CO3). 

(6) Formalin fixation. 

(7) Another method approved by 

HHS/CDC. 

Through this definition within the 

DFR, HHS/CDC is better clarifying and 

explaining existing practices that limit 

the importation of animal products that 

are known to transfer, or are capable of 

transferring, an infectious biological 

agent to a human. Such products must 

be accompanied by an HHS/CDC import 

permit or rendered noninfectious as a 

condition of entry into the United 

States. Items that have been rendered 

noninfectious, as described in this 

subpart, may be imported without an 

HHS/CDC permit. 

You or your. To best identify and 

assign responsibilities under this 

subpart, we have defined the terms 

‘‘you’’ or ‘‘your’’ to mean an importer, 

owner, or an applicant. 

VIII. Alternatives Considered 

Under Executive Order 13563 

agencies are asked to consider all 

feasible alternatives to current practice 

and the rulemaking. HHS/CDC notes 

that the main impact of the DFR is to 

clarify the current practices and intent 

of HHS/CDC by updating and defining 

terms used in the existing 42 CFR Part 

71. As explained in Section III. 

‘‘Rationale for Updates to 42 CFR 71.1, 

71.32(a) and 71.50,’’ through this DFR, 

HHS/CDC is also updating the Scope 

and Definitions for 42 CFR Part 71 

under sections 71.1 and add new 

section 71.50, to reflect modern 

terminology and plain language 

commonly used by global private sector 

industry and public health partners. By 

clarifying and explaining the provisions 

within part 71, HHS/CDC hopes to assist 

the regulated community in complying 

with the provisions to best protect 

public health. HHS/CDC believes that 

this rulemaking complies with the spirit 

of the Executive Order; updating 

definition and clarifying language 

provides good alternatives to the current 

regulation. 

IX. Required Regulatory Analyses 

A. Required Regulatory Analyses under 

Executive Orders 12866 and 13563 

Under Executive Order 12866 (EO 

12866), Regulatory Planning and Review 

(58 FR 51735, October 4, 1993) CDC is 

required to determine whether this 

regulatory action would be ‘‘significant’’ 

and therefore subject to review by the 

Office of Management and Budget 

(OMB) and the requirements of the 

Executive Orders. This order defines 

‘‘significant regulatory action’’ as any 

regulatory action that is likely to result 

in a rule that may: 

• Have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

state, local, or tribal governments or 

communities; 

• Create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

• Materially alter the budgetary 

impact of entitlements, grants, user fees, 

or loan programs or the rights and 

obligations of recipients; or, 

• Raise novel legal or policy issues 

arising out of legal mandates, the 


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75890 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 

President’s priorities, or the principles 

set forth in EO 12866. 

Executive Order 13563 (EO 13563), 

Improving Regulation and Regulatory 

Review, (76 FR 3821, January 21, 2011), 

updates some of the provisions of EO 

12866 in order to promote more 

streamlined regulatory actions. This EO 

charges, in part, that, while protecting 

‘‘public health, welfare, safety, and our 

environment’’ that regulations must also 

‘‘promote predictability and reduce 

uncertainty’’ in order to promote 

economic growth. Further, regulations 

must be written in common language 

and be easy to understand. In the spirit 

of EO 13563, this DFR enhances 

definitions related to control of 

communicable diseases and adds more 

recent medical information where 

appropriate. CDC has determined that 

this DFR is an update of definitions and 

compliant with the spirit of EO 13563. 

Further, CDC has determined that this 

DFR is not a significant regulatory 

action as defined in EO 12866 because 

the DFR is definitional and does not 

change the baseline costs for any of the 

primary stakeholders. 

B. Regulatory Flexibility Act 

We have examined the impacts of the 

rule under the Regulatory Flexibility 

Act (5 U.S.C. 601–612). Unless we 

certify that the rule is not expected to 

have a significant economic impact on 

a substantial number of small entities, 

the Regulatory Flexibility Act (RFA), as 

amended by the Small Business 

Regulatory Enforcement Fairness Act 

(SBREFA), requires agencies to analyze 

regulatory options that would minimize 

any significant economic impact of a 

rule on small entities. We certify that 

this rule will not have a significant 

economic impact on a substantial 

number of small entities within the 

meaning of the RFA. 

C. Small Business Regulatory 

Enforcement Fairness Act of 1996 

This regulatory action is not a major 

rule as defined by Sec. 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996. This rule will not 

result in an annual effect on the 

economy of $100,000,000 or more; a 

major increase in cost or prices; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

D. The Paperwork Reduction Act of 

1995 

HHS/CDC has determined that the 

Paperwork Reduction Act does apply to 

the date collection and record keeping 

requirements of 42 CFR Part 71 and has 

obtained approval by the Office of 

Management and Budget (OMB) under 

OMB Control No. 0920–0134, expiration 

07/31/2015. The updates in this rule do 

not impact the data collection and 

record keeping requirements already 

approved by OMB. 

E. National Environmental Policy Act 

(NEPA) 

Pursuant to 48 FR 9374 (list of HHS/ 

CDC program actions that are 

categorically excluded from the NEPA 

environmental review process), HHS/ 

CDC has determined that this action 

does not qualify for a categorical 

exclusion. In the absence of an 

applicable categorical exclusion, the 

Director, HHS/CDC, has determined that 

provisions amending 42 CFR Part 71 

will not have a significant impact on the 

human environment. Therefore, neither 

an environmental assessment nor an 

environmental impact statement is 

required. 

F. Civil Justice Reform (Executive Order 

12988) 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. Under this rule: (1) All State 

and local laws and regulations that are 

inconsistent with this rule will be 

preempted; (2) no retroactive effect will 

be given to this rule; and (3) 

administrative proceedings will not be 

required before parties may file suit in 

court challenging this rule. 

G. Executive Order 13132 (Federalism) 

HHS/CDC has reviewed this rule in 

accordance with Executive Order 13132 

regarding Federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The rule 

does not ‘‘have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

H. Plain Language Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS/CDC has 

attempted to use plain language in 

promulgating this rule consistent with 

the Federal Plain Writing Act and 

requests public comment on this effort. 

List of Subjects in 42 CFR Part 71 

Communicable diseases, Isolation, In 

transit, Public health, Quarantine, 

Quarantinable communicable disease, 

Render noninfectious. 

Amended Text 

For the reasons discussed in the 

preamble, the Centers for Disease 

Control and Prevention amends 42 CFR 

part 71 as follows: 

PART 71—FOREIGN QUARANTINE 

■ 1. The authority citation for part 71 

continues to read as follows: 

Authority: Secs. 215 and 311 of Public 

Health Service (PHS) Act, as amended (42 

U.S.C. 216, 243); secs. 361–369, PHS Act, as 

amended (42 U.S.C. 264–272). 

■ 2. Amend § 71.1 as follows: 

■ a. Revise paragraph (a). 

■ b. In paragraph (b), add in 

alphabetical order definitions of 

Commander, Quarantine, Quarantinable 

communicable disease, and U.S. 

territory. 

■ c. In paragraph (b), revise definitions 

of International Health Regulations, 

Isolation, Surveillance, United States, 

and Vector. 

The revisions and additions read as 

follows: 

§ 71.1 Scope and definitions. 

* * * * * 

(a) The provisions of this part contain 

the regulations to prevent the 

introduction, transmission, and spread 

of communicable disease from foreign 

countries into the States or territories 

(also known as possessions) of the 

United States. Regulations pertaining to 

preventing the interstate spread of 

communicable diseases are contained in 

21 CFR parts 1240 and 1250 and 42 CFR 

part 70. 

(b) * * * 

* * * * * 

Commander means the aircrew 

member with responsibility for the 

aircraft’s operations and navigation. 

* * * * * 

International Health Regulations or 

IHR means the International Health 

Regulations of the World Health 

Organization, adopted by the FiftyEighth World Health Assembly in 2005, 

as may be further amended, and subject 

to the United States’ reservation and 

understandings. 

* * * * * 

Isolation means the separation of an 

individual or group who is reasonably 

believed to be infected with a 

quarantinable communicable disease 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 75891 

from those who are healthy to prevent 

the spread of the quarantinable 

communicable disease. 

* * * * * 

Possession means U.S. territory. 

Quarantine means the separation of 

an individual or group reasonably 

believed to have been exposed to a 

quarantinable communicable disease, 

but who is not yet ill, from others who 

have not been so exposed, to prevent the 

possible spread of the quarantinable 

communicable disease. 

Quarantinable communicable disease 

means any of the communicable 

diseases listed in an Executive Order, as 

provided under § 361 of the Public 

Health Service Act (42 U.S.C. § 264). 

Executive Order 13295, of April 4, 2003, 

as amended by Executive Order 13375 

of April 1, 2005, contains the current 

revised list of quarantinable 

communicable diseases, and may be 

obtained at http://www.cdc.gov and 

http://www.archives.gov/ 

federal_register. If this Order is 

amended, HHS will enforce that 

amended order immediately and update 

that Web site. 

Surveillance means the temporary 

supervision by a public health official 

(or designee) of an individual or group, 

who may have been exposed to a 

quarantinable communicable disease, to 

determine the risk of disease spread. 

* * * * * 

U.S. territory means any territory (also 

known as possessions) of the United 

States, including American Samoa, 

Guam, the Northern Mariana Islands, 

the Commonwealth of Puerto Rico, and 

the U.S. Virgin Islands. 

United States means the 50 States, 

District of Columbia, and the territories 

(also known as possessions) of the 

United States, including American 

Samoa, Guam, the Northern Mariana 

Islands, the Commonwealth of Puerto 

Rico, and the U.S. Virgin Islands. 

Vector means any animals (vertebrate 

or invertebrate) including arthropods or 

any noninfectious self-replicating 

system (e.g., plasmids or other 

molecular vector) or animal products 

that are known to transfer, or are 

capable of transferring, an infectious 

biological agent to a human. 

■ 3. Revise § 71.32(a) to read as follows: 

§ 71.32 Persons, carriers, and things. 

(a) Whenever the Director has reason 

to believe that any arriving person is 

infected with or has been exposed to 

any of the communicable diseases listed 

in an Executive Order, as provided 

under section 361(b) of the Public 

Health Service Act, he/she may isolate, 

quarantine, or place the person under 

surveillance and may order disinfection 

or disinfestation, fumigation, as he/she 

considers necessary to prevent the 

introduction, transmission or spread of 

the listed communicable diseases. 

Executive Order 13295, of April 4, 2003, 

as provided under section 361 of the 

Public Health Service Act (42 U.S.C. 

264), and as amended by Executive 

Order 13375 of April 1, 2005, contains 

the current revised list of quarantinable 

communicable diseases, and may be 

obtained at http://www.cdc.gov and 

http://www.archives.gov/federalregister. If this Order is amended, HHS 

will enforce that amended order 

immediately and update this reference. 

* * * * * 

■ 4. Add § 71.50 to subpart F to read as 

follows: 

§ 71.50—Scope and definitions. 

(a) The purpose of this subpart is to 

prevent the introduction, transmission, 

and spread of communicable human 

disease resulting from importations of 

various animal hosts or vectors or other 

etiological agents from foreign countries 

into the United States. 

(b) In addition to terms in § 71.1, the 

terms below, as used in this subpart, 

shall have the following meanings: 

Animal product or Product means the 

hide, hair, skull, teeth, bones, claws, 

blood, tissue, or other biological 

samples from an animal, including 

trophies, mounts, rugs, or other display 

items. 

Educational purpose means use in the 

teaching of a defined educational 

program at the university level or 

equivalent. 

Exhibition purpose means use as part 

of a display in a facility comparable to 

a zoological park or in a trained animal 

act. The animal display must be open to 

the general public at routinely 

scheduled hours on 5 or more days of 

each week. The trained animal act must 

be routinely schedule for multiple 

performances each week and open to 

the general public except for reasonable 

vacation and retraining periods. 

In transit means animals that are 

located within the United States, 

whether their presence is anticipated, 

scheduled, or not, as part of the 

movement of those animals between a 

foreign country of departure and foreign 

country of final destination without 

clearing customs and officially entering 

the United States. 

Isolation when applied to animals 

means the separation of an ill animal or 

ill group of animals from individuals, or 

other animals, or vectors of disease in 

such a manner as to prevent the spread 

of infection. 

Licensed veterinarian means an 

individual who has obtained both an 

advanced degree and valid license to 

practice animal medicine. 

Person means any individual or 

partnership, firm, company, 

corporation, association, organization, 

or similar legal entity, including those 

that are not-for-profit. 

Quarantine when applied to animals 

means the practice of separating live 

animals that are reasonably believed to 

have been exposed to a communicable 

disease, but are not yet ill, in a setting 

where the animal can be observed for 

evidence of disease, and where 

measures are in place to prevent 

transmission of infection to humans or 

animals. 

Render noninfectious means treating 

an animal product (e.g., by boiling, 

irradiating, soaking, formalin fixation, 

or salting) in such a manner that renders 

the product incapable of transferring an 

infectious biological agent to a human. 

Scientific purpose means use for 

scientific research following a defined 

protocol and other standards for 

research projects as normally conducted 

at the university level. The term also 

includes the use for safety testing, 

potency testing, and other activities 

related to the production of medical 

products. 

You or your means an importer, 

owner, or an applicant. 

Dated: December 13, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–30723 Filed 12–21–12; 4:15 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2012–0003; Internal 

Agency Docket No. FEMA–8261] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 


tkelley on DSK3SPTVN1PROD with